MAUDE Adverse Event Report: ORTHOFIX SRL TITANIUM LOCKING SCREW D.4.0 MM-L.25 MM

Model Number 99-T74425

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records.Orthofix (b)(4) checked the internal records related to the controls made on the (b)(4) lot v1205741 before the market release.No anomalies have been found.The original lot, manufactured in july 2011, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation: the technical evaluation of the device involved will be performed as soon as the device becomes available.Medical evaluation: the information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once further information and/or the technical analysis investigation is available.As soon as further information is available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2016-00056.Device not returned.

Event Description

The information provided by the local distributor indicates: hospital name: hospital (b)(6), surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: left humeral; surgery description: fracture treatment; patient's information: (b)(6), male, previous health condition: normal problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: during the surgery both devices broke between the screw head and body at moment of distal locking handling.The broken screws are still in the patient, because the physician expects to explant them when the nail removal will be performed.Note: the head of screws are available to return for investigation.The complaint report form also indicates: the device failure had adverse effects on patient; the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event led to a clinically relevant increase in the duration of the surgical procedure -total duration of the surgical procedure: 5 hours; the estimative of extra time needed due to the screws failure is 40 min.An additional surgery was not required; copies of the operative reports are not available; copies of the xrays images are not available; information on patient current health condition: patient is in good health conditions.Further information received from local distributor on june 17, 2016: date of initial surgery (b)(6) 2016.In the total duration of the surgery of 5 hours, the estimative of extra time needed due to the screws failure is 40min.We will return the portion of screws.Please also kindly refer to mfr report 9680825-2016-00056.(b)(4).

Manufacturer Narrative

Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t74425, lot v1205741 before the market release.No anomalies have been found.The original lot, manufactured in july 2011, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.This item and lot number was already involved in a commercial action on the market implemented in april 2012, ref: in (b)(4).Orthofix (b)(4) requested all affected distributors to discontinue and return all items and lots involved in in (b)(4).The two screws involved in this event were not returned by the distributor in year 2012, as required by orthofix (b)(4), as they remained at the sub-distributor warehouse.The local distributor (b)(4) confirmed that no other devices and lot numbers of the ones involved in the in (b)(4) are still on the (b)(4) market.Based on the results of risk analysis re-evaluation, orthofix (b)(4) would like to assure that this potential defect does not pose any unacceptable risk to the patients or users.Orthofix (b)(4) would like to inform that the last sale on the us market o the item involved in this event, code 99-t74425 titanium locking screw d.4.0 mm-l.25 mm, was in year 2011.Technical evaluation: the broken portions of the returned devices, received on july 27, 2016 were examined by orthofix (b)(4) quality engineering area.The screw heads were subjected to visual and dimensional check as per orthofix (b)(4) design and product specification.The visual check confirmed that the screws broke at screw head level.The dimensional check performed where possible (on the hexagons of the screw heads) confirmed that they were originally conforming to the design specifications.No functional test could be performed because only screw heads were provided.A complete technical analysis could not be finalized as only screw heads were returned for investigation.However, since the products are belonging to a previous revision of the drawing where the length of the cylindrical part of the hole for the hexagon was not specified, we may suppose that the breakage occurred was related to the fact that the resistant section was insufficient to withstand the torque applied because the hole was too deep.Medical evaluation: the information made available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed."in this case, a (b)(6)-year-old male patient was having a humeral nail inserted for fracture treatment.The humeral nail was 7 mm, 215 mm long, and 4 locking screws were used: 2 x 25 mm, 1 x 30 mm and 1 x 35 mm.We are not told any more details about the patient.The operation apparently took 5 hours.During locking screw insertion 2 of the locking screw heads broke off.The rest of the locking screw remained in the patient in each case.We are told that the incident of the broken screw heads increased the operation time by 40 minutes.I have the following comments: 5 hours is a very excessive time for a humeral nail insertion (normally well under 60 minutes), so there must have been other complicating factors that we have not been told about.Although the screw heads have broken off, the locking screws will still be performing their function as planned.The screw thread will grip the bone and hold it in place, and hold the nail locked as intended.It is very difficult to see what intervention the surgeon might have tried to do without removing the locking screws, which he did not attempt to do.I therefore regard the estimate of 40 minutes extra operating time as questionable.I think that a maximum of 5 minutes extra time would have been caused.This would not be clinically significant.So the operation was completed as planned with the humeral nail in situ and locked with 4 locking screws.I am assuming that the nail locking was satisfactory; we have not been told that it was not." final comments: a complete technical analysis could not be finalized as only screw heads were returned for investigation.However, since the products are belonging to a previous revision of the drawing where the length of the cylindrical part of the hole for the hexagon was not specified, we may suppose that the breakage occurred was related to the fact that the resistant section was insufficient to withstand the torque applied because the hole was too deep.Please be informed that a corrective action (azisch (b)(4)) was taken in order to avoid the recurrence of this kind of problem in the future and a containment action was done asking to return all the devices potentially involved through an informative note (in (b)(4)).Based on the results of risk analysis re-evaluation, orthofix (b)(4) would like to assure that this potential defect does not pose any unacceptable risk to the patients or users.A complete medical evaluation was not possible as no information about the medical procedure, patient conditions, diagnosis and x-rays have been made available.Based on the few information available on the event and due to the fact that only a portion of the devices involved in this event was returned, it was not possible to finalize the investigation and determine the root cause of the event notified.Orthofix (b)(4) historical records shows that no other similar notifications have been received in regards to this specific device lot.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2016-00056 follow up 1.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6), surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: left humeral; surgery description: fracture treatment; patient's information: (b)(6) years old, male, previous health condition: normal.Problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: during the surgery, both devices broke between the screw head and body at moment of distal locking handling.The broken screws are still in the patient, because the physician expects to explant them when the nail removal will be performed.Note: the head of screws are available to return for investigation.The complaint report form also indicates: the device failure had adverse effects on patient; the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event led to a clinically relevant increase in the duration of the surgical procedure -total duration of the surgical procedure: 5.Hours; the estimative of extra time needed due to the screws failure is 40 min.An additional surgery was not required; copies of the operative reports are not available; copies of the xrays images are not available; information on patient current health condition: patient is in good health conditions.Further information received from local distributor on june 17, 2016: date of initial surgery (b)(6) 2016.In the total duration of the surgery of 5 hours, the estimative of extra time needed due to the screws failure is 40min.We will return the portion of screws.Further information received from local distributor on june 20, 2016: the two screws involved in this event were not returned in year 2012, as required by orthofix (b)(4), as they remained at the subdistributor warehouse.Please also kindly refer to mfr report 9680825-2016-00056 follow up 1.(b)(4).

• Brand Name: TITANIUM LOCKING SCREW D.4.0 MM-L.25 MM
• Type of Device: TITANIUM LOCKING SCREW D.4.0 MM-L.25 MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012 ; 0456719000
• MDR Report Key: 5778549
• MDR Text Key: 49051711
• Report Number: 9680825-2016-00057
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 18032568868487
• UDI-Public: (01)18032568868487(10)V1205741(11)110705(17)160605
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K053261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 99-T74425
• Device Catalogue Number: 99-T74425
• Device Lot Number: V1205741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR